[Congressional Record (Bound Edition), Volume 145 (1999), Part 21]
[Senate]
[Pages 31209-31210]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 AMENDING THE PUBLIC HEALTH SERVICE ACT

  Ms. COLLINS. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of S. 1996, introduced by 
Senators Jeffords, Kennedy, and Frist.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 1996) to amend the Public Health Service Act to 
     clarify provisions relating to the content of petitions for 
     compensation under the vaccine injury compensation program.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. JEFFORDS. Mr. President, in 1986, the Vaccine Injury Compensation 
Act was signed into law. The act created the National Vaccine Injury 
Compensation program which serves two important functions: it provides 
timely and fair compensation to those few children who are injured from 
routine

[[Page 31210]]

immunization and it reduces the adverse effect of the tort system on 
vaccine supply and cost. Prior to enactment of this bill, the number of 
U.S. manufacturers of children's vaccines dropped from seven to two due 
to a flood of lawsuits filed in response to a network television 
broadcast claiming that vaccine causes brain injuries. This program has 
been very successful. However, it has come to our attention that the 
act requires an amendment which I, and the Senator from Massachusetts 
and the Senator from Tennessee offer today.
  A vaccine becomes part of the compensation program if it is 
recommended for routine use in children by the Centers for Disease 
Control. At such time, the Congress must also enact a Federal excise 
tax on the vaccine (currently at $.75 per antigen in the vaccine). The 
excise tax revenues are housed in a Federal trust fund, the sole 
purpose of which is to pay claims and administer this program. The 
program and the fund is jointly administered by the Department of 
Health and Human Services (HHS) and the Department of Justice.
  HHS publishes a table listing all covered vaccines and events that 
may be associated with those vaccines as determined by valid scientific 
studies. Events that are listed on the table, if they occur within the 
listed time frame, are automatically compensated by the program unless 
there is demonstration that some other circumstances created the 
injury. For an event/injury not listed on the table, the claimant must 
prove causation.
  If a vaccine is covered under the Vaccine Injury Compensation 
program, all claims against it must first be filed and processed 
through the program. Once a claim is adjudicated (and either an award 
is made or the claim denied), a claimant can reject the program's 
determination and opt to file a lawsuit.
  Since the benefit of taking a vaccine accrues not only to the 
recipient but to society as a whole, the Congress decided that it was 
also society's responsibility to compensate those who are injured by 
creating a no-fault program that removes the costliness and uncertainty 
of the tort system. At the time this law was enacted, parameters were 
established to permit claims for those serious adverse events that were 
known to be associated with those vaccines that were then available. 
The statutory proxy for a serious injury is that the residual effect 
from the injury must be of six months' duration or longer.
  Recently, however, a new situation has developed that was not 
foreseeable at the time of enactment of this law. In October 1999, the 
CDC's Advisory Committee on Immunization Practices (ACIP), after a 
review of scientific data from several sources, concluded that 
intussusception occurs with significantly increased frequency in the 
first 1-2 weeks after vaccination for rotavirus, particularly after the 
first dose. Thus, the ACIP withdrew its recommendation for vaccination 
of infants for rotavirus in the United States.
  While most cases of intussusception require only minimal treatment, a 
few cases require hospitalization and surgery. Under the current law, 
these cases would not be compensable by the United States Claims Court 
under the Vaccine Injury Compensation Program, since the statute grants 
jurisdiction to resolve vaccine cases only in instances in which 
claimants have suffered the residual effects or complications of a 
vaccine-related injury for at least six months, or died from the 
administration of a vaccine.
  For this reason, we are offering this bill to amend the law and grant 
jurisdiction to the Claims Court to resolve compensation cases under 
the Program in cases in which both hospitalization and surgical 
intervention were required to correct the ``illness, disability, injury 
or condition'' caused by the vaccine. Mr. President, this language has 
been shared with, and is supported by officials at HHS and the American 
Academy of Pediatrics.
  To our knowledge, the amendment would only apply to circumstances 
under which a vaccine recipient suffered from intussusception as a 
result of administration of the rotavirus vaccine. The amendment is not 
intended to expand jurisdiction to other vaccines listed in the 
Program's Vaccine Injury Table.
  We note that this amendment does not address the issue of whether the 
condition is in fact caused by the vaccine; this is a matter for 
resolution under other provisions of the no-fault compensation law. 
Among these are the requirement that the condition either be listed in 
the Vaccine Injury Table or be established to have been caused in fact 
by the vaccine. Determinations of this type should only be made after 
thorough consideration of the scientific evidence by experts in the 
field; the law commits this issue to the Secretary for consideration in 
the context of changes to the Vaccine Injury Table through rulemaking, 
and to the Claims Court for determinations of causation in fact.
  Mr. KENNEDY. Mr. President, I join the Senator from Vermont and the 
Senator from Tennessee in proposing legislation to amend the Vaccine 
Injury Compensation Program.
  This program is an important part of the nation's public health 
strategy. In order to encourage the development and use of effective 
vaccines, the program guarantees compensation to the few children who 
are injured by routine immunization.
  Recent evidence suggests that some children may suffer vaccine-
related injuries that are not covered under the current criteria used 
to determine eligibility for compensation. To continue the program's 
success, Congress must assure that the system is responsive to new 
developments in medical science. We need to be certain that any child 
who suffers a severe injury as a result of routine vaccination is 
eligible for compensation under the program.
  My colleague from Vermont has concisely summarized the current status 
of the program and the importance of amending the statute. Families and 
physicians need to know that public health procedures are capable of a 
rapid and appropriate response to scientific developments. It is a 
privilege to join my colleagues in offering this legislation to improve 
the Vaccine Injury Compensation Program.
  Ms. COLLINS. Mr. President, I ask unanimous consent that the bill be 
read a third time and passed, the motion to reconsider be laid upon the 
table, and that statements relating to the bill be printed in the 
Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 1996) was read the third time and passed, as follows:

                                S. 1996

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

       Section 2111(c)(1)(D) of the Public Health Service Act (42 
     U.S.C. 300aa-11(c)(1)(D)) is amended by striking ``and'' at 
     the end and inserting ``or (iii) suffered such illness, 
     disability, injury or condition from the vaccine which 
     resulted in inpatient hospitalization and surgical 
     intervention to correct such illness, disability, injury or 
     condition, and''.

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